1. Field of the Invention
The present invention relates to medical devices which are compatible with procedures performed during magnetic resonance imaging (MRI), and particularly to medical devices which can deliver drugs during procedures viewed with magnetic resonance (MR) imaging techniques.
2. Background of the Art
Medical procedures may now be performed on areas of the patient which are relatively small. Procedures may be performed on small clusters of cells, within veins and arteries, and in remote sections of the body with minimally invasive techniques, such as without surgical opening of the body. As these procedures, such as balloon angioplasty, microsurgery, electrotherapy, and drug delivery are performed within the patient with minimally invasive techniques without major surgical opening of the patient, techniques have had to be developed which allow for viewing of the procedure concurrent with the procedure. X-ray imaging, such as X-ray fluoroscopy, is a possible method of providing a view of the procedural area, but X-ray exposure for any extended period of time is itself harmful to the patient. Fiber optic viewing of the area does not provide any harmful radiation to the patient, but the fiber optics may take up too large a space to provide both the light necessary for viewing and a path for return of the light, and does not permit beyond the surface imaging (that is, only the surfaces of internal objects may be viewed from the position where the fiber optic device is located). Fiber optics or direct light viewing is more acceptable for larger area medical procedures such as gastroenterological procedures than for more microscopic procedures such as intraparenchymal drug delivery or endovascular drug delivery or procedures.
Techniques have been developed for relatively larger area viewing of MR-compatible devices within a patient by the use of MR-receiver coils in the devices which are tracked by MR imaging systems. Little by way of specific design considerations have been given to devices which have MR viewing capability and specific treatment functions, and especially where the relationship of specific types of treatment and the MR receiver coils must be optimized both for a treatment process and for MR viewing ability.
U.S. Pat. No. 5,211,165 describes a tracking system to follow the position and orientation of an invasive device, and especially a medical device such as a catheter, using radio frequency field gradients. Detection of radio frequency signals is accomplished with coils having sensitivity profiles which vary approximately linearly with position. The invasive device has a transmit coil attached near its end and is driven by a low power RF source to produce a dipole electromagnetic field that can be detected by an array of receive coils distributed around an area of interest of the subject. This system places the transmit coils within the subject and surrounds the subject with receive coils.
U.S. Pat. No. 5,271,400 describes a tracking system to monitor the position and orientation of an invasive device within a subject. The device has an MR active sample and a receiver coil which is sensitive to magnetic resonance signals generated by the MR active sample. These signals are detected in the presence of magnetic field gradients and thus have frequencies which are substantially proportional to the location of the coil along the direction of the applied gradient. Signals are detected responsive to sequentially applied mutually orthogonal magnetic gradients to determine the device's position in several dimensions. The invasive devices shown in FIGS. 2a and 2b and rf coil and an MR active sample incorporated into a medical device and an MR active sample incorporated into a medical device, respectively.
U.S. Pat. No. 5,375,596 describes a method and apparatus for determining the position of devices such as catheters, tubes, placement guidewires and implantable ports within biological tissue. The devices may contain a transmitter/detector unit having an alternating current radio-frequency transmitter with antenna and a radio signal transmitter situated long the full length of the device. The antennae are connected by a removable clip to a wide band radio frequency (RF) detection circuit, situated within the transmitter/detector unit.
U.S. Pat. No. 4,572,198 describes a catheter for use with NMR imaging systems, the catheter including a coil winding for exciting a weak magnetic field at the tip of the catheter. A loop connecting two conductors supports a dipole magnetic field which locally distorts the NMR image, providing an image cursor on the magnetic resonance imaging display.
U.S. Pat. No. 4,767,973 describes systems and methods for sensing and movement of an object in multiple degrees of freedom. The sensor system comprises at least one field-effect transistor having a geometric configuration selected to provide desired sensitivity.
Published PCT Applications WO 93/15872, WO 93/15874, WO 93/15785, and WO 94/27697 show methods of forming tubing, including kink resistant tubing and catheters in which the catheters may contain reinforcing coils. Layer(s) of reinforcing materials may be deposited on and over the reinforcing coils.
U.S. Patent Nos. 5,451,774 and 5,270,485 describes a three-dimensional circuit structure including a plurality of elongate substrates positioned in parallel and in contact with each other. Electrical components are formed on the surfaces of the substrates, along with electrical conductors coupled to those components. The conductors are selectively positioned on each substrate so as to contact conductors on adjacent substrates. The conductor patterns on the substrates may be helical, circumferential, or longitudinal. Radio frequency signaling between substrates would be effected with a transmitting antenna and a receiving antenna, with radio frequency signal transmitting and receiving circuitry present in the substrates (e.g., column 7, lines 32-43). Circulation of cooling fluid within the device is shown.
U.S. Pat. No. 5,273,622 describes a system for the fabrication of microstructures (including electronic microcircuitry) and thin-film semiconductors on substrates, especially continuous processes for use on elongate substrates such as fibers or filaments.
U.S. Pat. Nos. 5,106,455 and 5,269,882 describes a method and apparatus for fabrication of thin film semiconductor devices using non-planar exposure beam lithography. Circuitry formed on cylindrical objects is shown.
U.S. Pat. No. 5,167,625 describes a multiple vesicle implantable drug delivery system which may contain an electrical circuit which is responsive to signals (including radio signals) which can be used to effect drug delivery.
PCT Application WO 96/33761 (filed Apr. 15, 1996) describes an intraparenchymal infusion catheter system for delivering drugs or other agents comprising a pump coupled to the catheter. A porous tip is disposed at a distal end of the catheter, the tip being porous to discharge an agent or rug at a selected site. The catheter may be customized during use by an expandable portion of the catheter system.
Martin, A. J., Plewes, D. B. and Henkelman, R. M. in "MR Imaging of Blood Vessels with an Intravascular Coil," J. Mag. Res. Imag., 1992, 2, No.4, pp. 421-429 describes a method for producing high-resolution magnetic resonance (MR) images of blood vessel walls using a theoretic receiver-coil design based on two coaxial solenoids separated by a gap region and with the current driven in opposite directions. The coils had diameters ranging from 3 to 9 mm. FIG. 3b appears to indicate that sensitivity decreases as the coils diameter moved from 9 to 7 to 5 to 3 mm. Investigation of the Q value of opposed loop and opposed solenoid coils indicated that opposed loop coils displayed low W values and that there was a general trend of lower Q values at smaller Q diameters among the opposed solenoid designs. Within the range investigated, it was stated that a compromise exists between the use of thicker wire for improved performance and thinner wire to limit the overall coil dimensions. Decoupling circuitry is also shown to be useful in performing the imaging functions with this catheter based system in MR imaging.
Hurst, G. C., Hua, J., Duerk, J. I. and Choen, A. M., "Intravascular (Catheter) NMR Receiver Probe: Preliminary Design Analysis and Application in Canine Iliofemoral Imaging," Magn. Res. In Imaging, 24, 343-357 (1992) explores the feasibility of a catheter-based receiver probe for NMR study of arterial walls. Various potential designs, including opposed solenoids (e.g., FIG. 2b and FIG. 3 a and b) are examined. The catheter probe shown in FIG. 3 was constructed with five turns of 28 gauge wire per solenoid, with 7.5 mm between solenoids and nominal solenoid diameters of 2.8 mm, with the probe resonating at 64 MHz with a 110-pf capacitor.